Cooper Surgical Gellhorn Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not accurately reflect the size of the product inside.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is limited to packaging mislabeling.
Plain-English summary
Cooper Surgical, Inc. is recalling 175 units of Gellhorn Flexible Pessaries, 3 inches (76mm), Part Number MXPGE3-. The recall is due to a labeling error where the outer package may not reflect the actual size of the pessary contained within.
A pessary is a medical device inserted into the vagina to support the uterus, bladder, and rectum. The affected product is Lot Number 117568. The devices were distributed nationwide in the United States and internationally to Australia, Canada, Colombia, Denmark, France, Holland, New Zealand, and Thailand.
Consumers and healthcare providers should stop using the affected pessaries and contact Cooper Surgical, Inc. for further instructions or a replacement.
The recalled product
- Product
- Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
- Manufacturer
- Cooper Surgical, Inc.
- Hazard
- Affected units
- 175
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number:117568
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Cooper Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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